Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Kuti
• Collaborator: Thrasher Research Fund
• Treatments: Meropenem; Thienamycins

Criteria

Inclusion Criteria:

• Cystic Fibrosis

• Hospitalized with acute pulmonary exacerbation

• Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment

Exclusion Criteria:

• Known allergy to meropenem

• Require less than 3 days of meropenem in the hospital

• Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen

• Known fungal or viral infection

• Females in their 2nd or 3rd trimester of pregnancy

• Moderate to severe renal dysfunction, as defined by a creatinine clearance less than 50 ml/min/1.73m2 (by use of Schwartz method)

• History of solid organ transplantation within previous 6 months

• Active or recent (within 30 days) participation in another antibiotic clinical trial